1. Field of the Invention
The field of the invention is saliva sampling devices.
2. Description of the Prior Art
The current literature indicates saliva is used to conveniently, easily, safely and effectively test an individual for a variety of medical conditions. These tests for medical conditions include a hepatitis screening for restaurant employees, HIV, continue (nicotine) and cocaine screening by insurance companies and a five minute HIV screening by a dentist. Clinics for oncology, neurology, infertility, allergy orthopedic and pain which had used urine, blood and serum samples to determine the medical conditions of their patients are now using samples of saliva for this same purpose.
U.S. Pate. No. 5,079,170 teaches a sample applicator for use in performing immunoassays which includes a tube which defines an internal lumen and has a filter matrix at one end thereof. The sample is drawn into the applicator tube. The applicator may also include a reagent which is dispersed within a permeable matrix.
U.S. Pat. No. 5,077,198 teaches that diluent and wash compositions are useful in a rapid and sensitive assay for detecting antibodies, and especially retroviral antibodies, in a biological specimen. The diluent composition is buffered to a Ph of 6 to 10 and includes a protein or carbohydrate, a surfactant and a negatively-charged organic compound. The wash composition is buffered to a Ph of 5 to 10 and includes a surfactant. These compositions can be included in a diagnostic kit. The method includes mixing the biological specimen with the diluent composition, forming an immunological complex between ligand and antibodies in the specimen and separating complexed materials from uncomplexed materials using a filtration membrane and a washing step. An enzyme labeled anti-antibody is added to form a ligand-antibody-antibody complex followed by its detection using suitable reagents.
U.S. Pat. No. 4,834,110 teaches a selective collector of a human patient's saliva for monitoring or analysis is formed as a substantially conical flat concave cup of resilient molded polymer with tubing connections at an apex portal, and a large entrance portal having a soft compliant foam elastomer rim positioned for contact with the patient's soft tissue, such as the interior of the patient's cheek around the parotid salivary duct. Suction is connected to the soft foam rim, holding the concave cup in position, and suction, fixed pressure, pulsing pressure or electrical stimulation may promote the flow of saliva to a collector vessel. U.S. Pat. No. 4,768,238 teaches a bifurcated vessel for the collection of saliva.
U.S. Pat. No. 4,150,950 teaches a sampling device which includes a container, a seal, a screw-cap, an elongated element and a specimen collector. The container has a liquid reagent which the seal seals into the bottom portion thereof capable of preserving the activity of a particular specimen. The specimen collector is attachable to the inside of the screw cap through the elongated element which is of sufficient length to immerse the specimen collector into the liquid. After a specimen has been obtained, the specimen collector, which is attached to the screw cap, is forced through the seal into the liquid preservative as the screw cap is fastened tightly onto the container.
U.S. Pat. No. 4,774,962 teaches a method of extracting human saliva in which a resilient absorbent inert body is chewed by a person and is subsequently introduced into a centrifuge tubule provided with an apertured floor. The centrifuge tubule is introduced into a centrifuge and subjected to a spinning process, whereupon the saliva is pressed out of the resilient body and passes through the floor into the lower part of the centrifuge tubule.
U.S. Pat. No. 4,992,296 teaches a drug abuse test papers which are bibulous paper carriers which have been impregnated with specific test chemicals, including bismuth nitrate, potassium iodide, acetic acid, and platinum salt, in two coatings and dried after each coating under specific temperature conditions. The test chemicals are provided for the detection of the drug abuse compounds of amphetamine, cocaine, marijuana, and narcotics contained in low concentrations in animal or human urine.
U.S. Pat. No. 4,635,488 teaches a body fluid sampling device which includes a hollow tube with a solid, porous, water-wetable non-fibrous nib mounted in and protrudes from one end of the tube for collecting, by absorption, a sample of a body fluid such as sweat, tears, or saliva. The sample may be extracted from the nib for analysis by supplying an extraction fluid to the interior of the tube for gravity. Alternatively, a strip of paper, which contains an agent that changes appearance to indicate the presence of a substance to be detected, may be disposed in the hollow tube for endwise contact with the nib to receive the sample or components thereof by absorption.
U.S. Pat. No. 4,580,577 teaches a method for collecting saliva from a test subject which includes providing a flavored absorbent sponge for mastication and charging it with saliva and then expressing the saliva from the flavored absorbent sponge. The apparatus for this method includes a barrel-piston arrangement in association with a specimen vial for storage until diagnostic testing.
U.S. Pat. No. 4,817,632 teaches an oral fluid collection article for placement in the buccal cavity of an individual for the collection and filtering of a saliva fluid. The collection article has a semi-permeable membrane container enclosing an osmotic membrane.
U.S. Pat. No. 4,607,009 teaches an assay for determining the Lewis blood group of a patient which consists of testing a body sample for the presence of Lewis antigens. Mono-clonal antibodies specific for either of these antigens are employed which do not cross-react with other related antigens. Body samples which may be tested include saliva, serum, urine, and paraffin-embedded tissue samples.
U.S. Pat. No. 4,720,455 teaches a test kit of several reagents, test tubes and a dip-stick carrying an anti-progesterone mono-clonal antibody. U.S. Pat. No. 4,722,889 teaches a reagent kit is provided for assay of a selected antigen in an aliquot of body fluid.
U.S. Pat. No. 4,769,216 teaches a test kit which is used in detecting or determining the presence of antigenic or haptenic substances or antibodies in a sample. The test kit includes a plurality of tubular or capillary elements, each having antibodies or antigenic or haptenic substances attached to an internal surface thereof, and mechanism for causing fluids to pass simultaneously or sequentially through the plurality of capillary elements.
U.S. Pat. No. 4,771,486 teaches a sputum sampling device having capability for sputum-saliva separation which includes a substantially circular cup having a wall portion which tapers inwardly from top to bottom, a separation plate having a substantially elliptical planar configuration, the major and minor axis of the plate being dimensioned to allow insertion of the plate down into the cup at a slant to position the lower portion of the plate a distance above the bottom of the cup, a plurality of apertures formed in the lower portion of the plate to provide saliva drainage ports, and an upper portion of the plate comprising a roughened textured surface for retracting and holding sputum in position for recovery in order to obtain a sensory and microbiological examination.
U.S. Pat. No. 4,853,325 teaches a saliva test for feline leukemia virus (FeLV) which includes a probe which has an immuno-chemically sensitive member for collecting saliva from the oral cavity of a cat. The probe employs ELISA reagents for the incubation of the probe and the development of color reactions to indicate the presence or absence of FeLV within the saliva sample collected onto the probe.
U.S. Pat. No. 4,468,470 teaches a method for the assay of antibodies to soluble antigens in an aqueous sample in body fluids, such as blood serum or blood plasma, by contacting the sample with an antigen in vitro. The antibodies, if present, are bound by the antigens.
U.S. Pat. No. 4,929,544 teaches that human cancer is diagnosed/monitored by measuring an antigen level in a physiological fluid specimen of a subject by a quantitative immunoassay. That antigen level is then compared to the antigen level of that occurs in corresponding physiological fluid of normal subjects to determine whether the former is substantially elevated over the latter.
U.S. Pat. No. 4,942,122 teaches a kit which detects the presence of an antibody inhibiting HIV reverse transcriptase. The amount of antibody inhibiting HIV reverse transcriptase present in the body fluids of a patient known to be immuno-positive for HIV gives the clinician a means to form a prognosis for each individual case.
U.S. Pat. No. 4,447,528 teaches a radio-assay reagent kit for detecting auto blocking antibody. A receptor is immobilized on a support and the amount of ligand capable of binding therewith in the presence of a biological fluid sample is determined.
U.S. Pat. No. 4,865,966 teaches a method of screening mammals for antibodies to viral agents in which a urine sample is collected from a mammal to be tested. The urine sample is assayed the sample for antibodies directed against the specific viral agent.